基础用户特征对 1 型糖尿病成人实时与间歇性扫描连续血糖监测获益的影响：ALERTT1 试验的调节分析。
The Impact of Baseline User Characteristics on the Benefits of Real-Time Versus Intermittently Scanned Continuous Glucose Monitoring in Adults With Type 1 Diabetes: Moderator Analyses of the ALERTT1 Trial.
机构信息
Department of Endocrinology, University Hospitals Leuven - KU Leuven, Leuven, Belgium.
Interuniversity Institute for Biostatistics and Statistical Bioinformatics, KU Leuven and University of Hasselt, Leuven, Belgium.
出版信息
J Diabetes Sci Technol. 2024 May;18(3):660-666. doi: 10.1177/19322968221128315. Epub 2022 Sep 29.
BACKGROUND
ALERTT1 showed that switching from intermittently scanned continuous glucose monitoring (isCGM) without alerts to real-time CGM (rtCGM) with alert functionality improved time in range (TIR; 70-180 mg/dL), glycated hemoglobin (HbA1c), time <54 mg/dL, and Hypoglycemia Fear Survey version II worry subscale (HFS-worry) score after six months in adults with type 1 diabetes (T1D). Moderator analyses aimed to identify certain subgroups that would benefit more from switching to rtCGM than others.
METHODS
Post hoc analyses of ALERTT1 evaluated the impact of 14 baseline characteristics on the difference (delta) in mean TIR, HbA1c, time <54 mg/dL, and HFS-worry score at six months between rtCGM and isCGM. Therefore, the delta was allowed to depend on each of these variables by including interactions in the moderator analysis model. Analyses were performed separately for each variable; variables with < .10 in the univariable analysis were combined into a single model.
RESULTS
Univariable analyses showed no dependency of delta TIR, HbA1c, or time <54 mg/dL on variables other than CGM type. Only delta HFS-worry score depended on baseline HbA1c ( = .0059), indicating less worries with rtCGM in people with baseline HbA1c <6.5% or ≥8%. Given < .10 for dependency of delta TIR on insulin therapy type (favoring multiple daily injections), baseline HbA1c, and baseline TIR, these variables were combined into a multivariable analysis; interactions were not statistically significant.
CONCLUSIONS
Except for HFS-worry score, no interactions between 14 baseline characteristics and the six-month intervention effect of rtCGM on TIR, HbA1c, or time <54 mg/dL were observed, supporting the conclusion of ALERTT1 that switching from isCGM without alerts to rtCGM with alert functionality is beneficial for a wide range of people with T1D.
背景
ALERTT1 研究表明，对于 1 型糖尿病（T1D）成人患者，与使用无报警功能的间歇性扫描连续血糖监测（isCGM）相比，切换至具有报警功能的实时连续血糖监测（rtCGM）可在六个月时改善时间在目标范围内（TIR；70-180mg/dL）、糖化血红蛋白（HbA1c）、时间＜54mg/dL 及低血糖恐惧调查量表第二版担忧分量表（HFS-worry）评分。该研究还进行了亚组分析，旨在确定从 isCGM 切换至 rtCGM 获益更多的特定亚组。
方法
对 ALERTT1 进行事后分析，评估了 14 项基线特征对 rtCGM 与 isCGM 治疗六个月后 TIR、HbA1c、时间＜54mg/dL 及 HFS-worry 评分差值的影响。因此，通过在调节分析模型中包含交互项，允许差值取决于这些变量中的每一个。分别对每个变量进行分析；在单变量分析中 ＜.10 的变量被合并为一个模型。
结果
单变量分析显示，TIR、HbA1c 或时间＜54mg/dL 的差值与 CGM 类型以外的变量无关。只有 HFS-worry 评分差值依赖于基线 HbA1c（ =.0059），这表明基线 HbA1c＜6.5%或≥8%的患者使用 rtCGM 时担忧更少。鉴于 TIR 差值依赖于胰岛素治疗类型（有利于多次注射）、基线 HbA1c 和基线 TIR 的 ＜.10，这些变量被合并为多变量分析；交互作用无统计学意义。
结论
除 HFS-worry 评分外，14 项基线特征与 rtCGM 治疗六个月的干预效果之间没有观察到 TIR、HbA1c 或时间＜54mg/dL 的相互作用，这支持了 ALERTT1 的结论，即从无报警功能的 isCGM 切换至具有报警功能的 rtCGM 对 T1D 患者有益。
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